The Avenue T implants are devices whose primary functions are to add
a solid structure to a graft so as to enable the stabilization of
intervertebral height, after discectomy, during the time of graft
setting and achieve a maximum surface of fusion. Various sizes of
these implants are available, so that adaptations can be made to take
into account the pathology and individual patient anatomy. In
addition, so as to favor bone growth, the Avenue T TLIF Cage must be
filled with bone graft.
Indications for Use
The Avenue T TLIF Cage System is indicated for intervertebral body
fusion of the lumbar spine, from L2 to S1, in skeletally mature
patients who have had six months of non-operative treatment. The
device is intended for use at either one level or two contiguous
levels for the treatment of degenerative disc disease (DDD) with up to
Grade I spondylolisthesis or retrolisthesis. DDD is defined as back
pain of discogenic origin with degeneration of the disc confirmed by
history and radiographic studies. The Avenue T TLIF Cage is designed
for use with or without integrated fixation and must be used in
conjunction with supplemental fixation cleared by FDA for use in the
lumbar spine. The device is implanted via a transforaminal approach
and intended for use with autograft and/or allogenic bone graft
composed of cancellous and/or corticocancellous bone graft to
Contraindications include, but are not limited to:
- Patients under treatment inhibiting bone fusion.
- Cardiac Problems
- Abuse of medicine, drugs, tobacco or
alcohol (which change the ossification power).
sensitivity, documented or suspected.
- Any mental or
neuromuscular disorder which would create an unacceptable risk of
fixation failure or complications in post-operative care.
- Bony abnormalities or bone stock compromised by disease (such as
osteopenia, osteoporosis), infection or prior implantation
preventing safe support and/or fixation to the implant.
- Morbid obesity can produce loads on the spinal system which can
lead to failure of the fixation of the device or to failure of the
- Recent infection, fever or
- Open wounds.
- Patients having
inadequate tissue coverage over the operative site.
- Other medical (for
example: anesthetics risks) or surgical conditions which would
preclude the potential benefit of spinal implant surgery such as the
presence of bone tumors, congenital abnormalities, elevation of
sedimentation rate unexplained by other diseases.
- Potential risks associated with the use of this system, which
may require additional surgery, include device component fracture,
loss of fixation, non-union, fracture of the vertebra, neurological
injury, and vascular or visceral injury.
- Implants damaged
in any way that can affect their form or functioning must not be
- Under no circumstances may the implants be
re-used. Although the device may appear intact on removal, internal
modification due to the stress and strains placed on it, or small
defects may exist which may lead to fracture of the implant.
- Implants removed from a patient that contact bodily tissues or
fluids should never be reused at risk of contamination of the
- Devices cannot withstand activity and loads equal to
those placed on normal healthy bone. Until arthrodesis of segment(s)
is confirmed, do not subject this device to the stress of heavy
loads, or implant failure may result.
- Mixing Metal: Some
degree of corrosion occurs on all implanted metal and alloys.
Contact of dissimilar metals (e.g. stainless steels and titanium),
however, may accelerate this corrosion process. The presence of
corrosion may accelerate fatigue fracture of implants and the amount
of metal compounds released into the body system may also
- Manufacturers employ different materials,
manufacturing specifications and differing design parameters.
Components of the Avenue T TLIF Cage system should not be used in
conjunction with components from any other manufacturer.
- The device can break if it is subjected to increased loading
associated with delayed union or non-union. If healing is delayed or
does not occur, the implant could eventually break due to material
fatigue. Factors, such as the patient weight, activity level, and
compliance to weight bearing or load bearing instructions, have an
effect in the stresses to which the implant may be subjected, and
may affect the longevity of the implant.
- Any decision by a
surgeon to remove the device should take into consideration such
factors as the risk to the patient of the additional surgical
procedure as well as the difficulty of removal.
removal should be followed by adequate postoperative management to
- Before implanting the Avenue T TLIF Cage,
the vertebral plates must be carefully prepared, being careful not
to weaken the cortical bone to avoid implant subsidence.
- The setting and possible repositioning of the Avenue T TLIF Cage
must be done with the cage holder attached to the cage.
not attempt to reposition the implant after anchoring plates have
been deployed into the vertebral endplates.
- As the Avenue T
implants must be used with supplemental fixation, close attention
should be paid during the insertion of the anchoring plates, in
order to limit risk of contact between the anchoring plates and
additional spinal hardware (e.g., pedicle screws).
Avenue T TLIF Cage system has not been evaluated for heating or
migration in the MR environment.
- Being a technically demanding procedure presenting a risk of
serious injury to the patient, the implantation of intervertebral
body fusion systems should be performed only by experienced spine
surgeons with specific training in the use of this system and who
have knowledge of the present instructions for use.
on fatigue testing results, when using the Avenue T TLIF Cage
system, the physician/surgeon should consider the levels of
implantation, patient weight, patient activity level, other patient
conditions, etc., which may impact on the performance of this
- Patients who smoke have been shown to have an
increased incidence of non-unions. Such patients should be advised
of this fact and warned of the potential consequences.
the patient is involved in an occupation or activity which applies
inordinate stress upon the implant (e.g., running, lifting of
significant loads, or muscle strain), resultant forces can cause
failure of the device.
- In some cases, progression of
degenerative disease may be so advanced at the time of implantation
that they substantially decrease the expected useful life to the
implant. In such cases, orthopedic devices may be considered only as
a delaying technique or to provide temporary relief.
clinical use, the surgeon should thoroughly understand all aspects
of the surgical procedure and limitations of the system. This device
is recommended for use only by surgeons familiar with preoperative
and surgical techniques, cautions and potential risks associated
with spinal surgery. Knowledge of surgical techniques, proper
reduction, selection and placement of implants, and pre- and
post-operative patient management are considerations essential to a
successful surgical outcome.
- Instructions for patient care
following treatment should be provided by the surgeon or another
- Patients should be
instructed in detail about the limitations of the implants,
including but not limited to the impact of excessive loading through
patient weight or activity, and should be taught to govern their
activities accordingly. Avenue T implants (cages and anchoring
plates) are load-sharing devices which hold a vertebra in alignment
until healing occurs. If healing is delayed or does not occur, the
implant could eventually break due to material fatigue.
- Risks associated with general surgery by transforaminal
approach, orthopedic surgery, and the use of general anesthesia
should be explained to the patient prior to surgery.
- Appropriate selection, placement and fixation of the spinal
system components are critical factors which affect implant service
life. Accordingly, strict adherence to the indications,
contraindications, precautions, and warnings for this product is
essential to potentially maximize service life.
- Care must
be taken to protect the components from being marred, nicked or
notched as a result of contact with metal or abrasive objects.
Alterations will produce defects in surface finish and internal
stresses which may become the focal point for eventual breakage of
- After any surgery, it is necessary to check
the proper position of the implants and to follow the evolution of
the fusion using appropriate techniques.
- For the anchoring
plates, it is imperative to respect the following points:
- During multi-level implantations, care should be taken
during plate selection to minimize the possibility of
interference with the adjacent plate.
- Ensure the cage
does not protrude proximally outside the intervertebral disc
space to be sure that the anchoring plates are properly
positioned in the vertebral body.
- If VerteBRIDGE is
used in conjunction with pedicle screws, use fluoroscopy to
verify the trajectory of the anchoring plates to avoid
impingement with pedicle screws.
- Sale of
this product is restricted to physicians.